Dafurag

Package Leaflet: Information for the Patient

Dafurag, 10 mg/mL, Oral Suspension

Furazidinum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dafurag and what is it used for
• 2. Important information before taking Dafurag
• 3. How to take Dafurag
• 4. Possible side effects
• 5. How to store Dafurag
• 6. Contents of the pack and other information

1. What is Dafurag and what is it used for

Dafurag is an antibacterial medicine used to treat urinary tract infections. The medicine contains the active substance furazidine, also known as furagin, which is a derivative of nitrofuran. Furazidine inhibits the growth of bacteria that cause urinary tract infections.
Dafurag is not effective against infections caused by bacteria of the genus Pseudomonas and most strains of the genus Proteus (Proteus vulgaris).

Indications for Use

Treatment of acute and chronic uncomplicated lower urinary tract infections caused by bacteria of the genus Escherichia coli in children and adults.

2. Important Information Before Taking Dafurag

When Not to Take Dafurag

• if you are allergic to furazidine or any of the other ingredients of this medicine (listed in section 6) or to nitrofuran derivatives;
• during the first three months of pregnancy;
• during the last month of pregnancy and childbirth, due to the risk of hemolytic anemia (red blood cell breakdown) in the newborn;
• in children under 3 months of age;
• if you have kidney failure;
• if you have diagnosed polyneuropathy, e.g. diabetic (nerve damage caused by high blood sugar levels);
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase - the medicine may cause red blood cell breakdown (hemolysis), which can lead to the development of hemolytic anemia.

Warnings and Precautions

Before starting to take Dafurag, discuss it with your doctor or pharmacist:

• if you have kidney or liver function disorders, nervous system disorders, anemia, electrolyte disturbances, vitamin B deficiency, or folic acid deficiency, or lung diseases, if you have diabetes, as furazidine may cause nerve damage. Peripheral nerve damage has been observed in patients treated with nitrofuran derivatives. This disorder can be irreversible and life-threatening in severe cases. Therefore, this medicine should be discontinued if symptoms of nervous system disorders occur (tingling, numbness, sensation of electric currents);
• if you have a fever, chills, cough, chest pain, shortness of breath. These may be symptoms of acute pulmonary reactions, which are sometimes observed in patients treated with nitrofuran derivatives. If such symptoms occur, the medicine should be discontinued immediately. These symptoms usually resolve quickly or very quickly after discontinuation of the medicine. In cases of chronic reactions, the severity of symptoms and their reversibility after discontinuation of the medicine depend on the duration of treatment after the first symptoms appear. Early recognition of the adverse reaction and discontinuation of the medicine are crucial. Pulmonary function impairment can be irreversible. Chronic reactions occurred in patients who took furazidine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients;
• if the medicine is used for a long time - the doctor will prescribe blood tests and will check kidney and liver function. Effect on laboratory tests The medicine may cause false-positive glucose test results in urine. Before submitting a urine sample for such a test, inform the medical staff that you are taking Dafurag.

Children

Dafurag can be used in children over 3 months of age.

Dafurag and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Be particularly careful when taking the following medicines:

• quinolone derivatives (e.g. nalidixic acid - an antibiotic) - furazidine may inhibit their antibacterial activity;
• probenecid and sulfinpyrazone (medicines used to treat gout) - may reduce the effectiveness of furazidine and increase its toxicity;
• aminoglycoside and tetracycline antibiotics - when given with furazidine, they enhance its antibacterial activity;
• chloramphenicol and ristomycin (antibiotics) - increase the hemotoxic effect of furazidine;
• antacids containing magnesium trisilicate, which reduce the absorption of furazidine, weakening its antibacterial activity;
• atropine (a spasmolytic and mydriatic agent) - may delay the absorption of furazidine, but the overall amount of absorbed substance does not change;
• vitamins of group B - increase the absorption of nitrofuran derivatives.

Dafurag with Food and Drink

Dafurag is best taken with meals containing protein, as it increases the absorption of furazidine.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Due to the lack of clinical data on the harmful effects of furazidine on the fetus or embryo, the medicine should not be used during the first trimester of pregnancy.
Due to the risk of causing hemolytic anemia in the fetus, special caution is advised in women during the third trimester of pregnancy.
The patient, in agreement with the attending physician, should regularly perform blood morphology tests (hemoglobin concentration, iron, and red blood cell count - erythrocytes).
The medicine should not be used during the period from the 38th week of pregnancy or childbirth due to the risk of hemolytic anemia (red blood cell breakdown) in the newborn.
Breast-feeding
The medicine passes into breast milk, so it should not be used during breast-feeding.
Fertility
Clinical studies have shown that nitrofuran derivatives have a negative effect on testicular function. The medicine may cause a decrease in sperm motility, reduce sperm secretion, and lead to pathological changes in sperm morphology.

Driving and Using Machines

There is no data on the effect of furazidine on the ability to drive vehicles and operate machines.
Ifnervous system disorders occur, such as dizziness, drowsiness, vision disturbances (see section 4), do not drive vehicles or operate machines.

Dafurag Contains Saccharose, Methyl Parahydroxybenzoate, Propyl Parahydroxybenzoate, Macrogolglycerol Ricinoleate, Ethanol, D-Limonene, and Linalool

Saccharose

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
1 mL of the medicine contains 476 mg of saccharose. This should be taken into account in patients with diabetes.

Methyl Parahydroxybenzoate and Propyl Parahydroxybenzoate

The medicine contains 2.142 mg of methyl parahydroxybenzoate and 0.238 mg of propyl parahydroxybenzoate per 1 mL of suspension. The medicine may cause allergic reactions (possible late reactions).

Macrogolglycerol Ricinoleate

The medicine contains 1.19 mg of macrogolglycerol ricinoleate per 1 mL of suspension. The medicine may cause gastrointestinal disorders and diarrhea.

Ethanol

This medicine contains 44 mg of alcohol (ethanol) in each 10 mL of suspension, which is equivalent to 0.44% (v/v). The amount of alcohol in 10 mL of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine.
A small amount of alcohol in this medicine will not have noticeable effects.

D-Limonene and Linalool

The medicine contains d-limonene and linalool, which may cause allergic reactions.

3. How to Take Dafurag

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Take the medicine orally, preferably with meals containing protein.
Before each use, shake the bottle for at least 30 seconds.
An oral syringe is attached to the packaging to facilitate dosing. After each use, the dispenser should be washed and dried.

Recommended Dose

Adults
First day of treatment: 10 mL 4 times a day,
subsequent days of treatment: 10 mL 3 times a day.
Children over 3 months of age
5-7 mg/kg body weight per day in 2-3 divided doses.
The medicine is used for 7-8 days. If necessary, the doctor may prescribe repeated treatment after 10-15 days.

Use in Children

The medicine can be used in children over 3 months of age.

Taking More Than the Recommended Dose of Dafurag

Due to the excretion of the medicine from the body through the kidneys, the risk of overdose is increased in patients with impaired kidney function. Overdose symptoms may occur, such as: headache, dizziness, allergic reactions, nausea, vomiting, anemia.
If such symptoms occur, seek medical attention immediately.

Missing a Dose of Dafurag

Do not take a double dose to make up for a forgotten dose.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop Taking the Medicine Immediately and Inform Your Doctor or Go to the Nearest Hospital if You Experience (Less Than 1 in 100 People)

• anaphylactic reactions (sudden local or systemic allergic reactions, including life-threatening anaphylactic shock);
• angioedema (severe allergic reaction - sudden swelling of the face, limbs, or joints without itching and pain). Swelling in the head and neck area can cause difficulty swallowing and breathing;
• severe skin reactions (exfoliative dermatitis, erythema multiforme - red-purple spots on the skin and/or mucous membranes, sometimes with blisters, fever, and joint pain, Stevens-Johnson syndrome - blisters on the skin and/or mucous membranes that form painful sores after rupture, often accompanied by fever, muscle and joint pain);
• acute, subacute, and chronic reactions to nitrofuran derivatives affecting the respiratory system. Chronic reactions occurred in patients who took the medicine for more than 6 months. Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonia) may occur, especially in elderly patients. Acute reactions to the respiratory system were manifested by fever, chills, cough, chest pain, shortness of breath, pleural effusion, changes in lung radiography, and eosinophilia. These usually resolved quickly or very quickly after discontinuation of the medicine. In cases of chronic reactions, the severity of symptoms and their reversibility after discontinuation of the medicine depend on the duration of treatment after the first symptoms appear. Early recognition of the adverse reaction and discontinuation of the medicine are crucial. Pulmonary function impairment can be irreversible;
  • -pseudomembranous colitis (severe disease of the large intestine manifested by diarrhea, headache, and fever);
  • itching, rash (itching, red bumps on the skin), urticaria (light red, itching blisters on the skin);
  • cyanosis due to methemoglobinemia (abnormal hemoglobin pigment in red blood cells that has lost the ability to bind and transport oxygen) blue discoloration of the skin with a chocolate-brown tint.

  Additionally, the Following Side Effects May Occur

  Frequently(occurring in 1 to 10 people in 100):

  • nausea, excessive gas;
  • headache.

  Less Than 1 in 100 People:

  • symptoms of drug-induced hepatitis, cholestatic jaundice (caused by an obstacle to bile flow), liver necrosis;
  • dizziness, drowsiness;
  • vision disturbances;
  • peripheral nerve damage (also with acute or irreversible course, especially in patients with impaired kidney function, anemia, diabetes, electrolyte disturbances, or vitamin B deficiency);
  • constipation, diarrhea;
  • symptoms of gastrointestinal disorders, abdominal pain, vomiting;
  • salivary gland inflammation;
  • pancreatitis;
  • hair loss;
  • infections with microorganisms resistant to furazidine;
  • fever, chills, malaise;
  • megaloblastic anemia (resulting from vitamin B or folic acid deficiency) or hemolytic anemia (caused by rapid breakdown of red blood cells) - may occur in people with glucose-6-phosphate dehydrogenase deficiency.

  Reporting Side Effects

  If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
  Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
  Jerozolimskie Avenue 181C, 02-222 Warsaw
  Phone: +48 22 49 21 301,
  Fax: +48 22 49 21 309,
  Website: https://smz.ezdrowie.gov.pl
  Side effects can also be reported to the marketing authorization holder.
  Reporting side effects will help to gather more information on the safety of the medicine.

  5. How to Store Dafurag

  Keep the medicine out of the sight and reach of children.
  Store in a temperature below 25°C. Do not store in the refrigerator, do not freeze.
  Do not use this medicine after the expiry date stated on the label and carton.
  The expiry date refers to the last day of the month.
  The shelf life after opening the bottle is 3 months.
  Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

  6. Contents of the Pack and Other Information

  What Dafurag Contains

  • The active substance of the medicine is furazidine, also known as furagin. 1 mL of oral suspension contains 10 mg of furazidine.
  • The other ingredients are: saccharose, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), macrogolglycerol ricinoleate, hydroxypropylcellulose, xanthan gum, natural orange flavor 72VP (orange oil, ethanol, d-limonene, linalol), purified water.

  What Dafurag Looks Like and What the Pack Contains

  The medicine is a yellow suspension with an orange flavor.
  The carton contains a brown glass bottle with 140 mL of suspension, closed with a white aluminum cap and an oral syringe with a scale every 0.1 mL.

  Marketing Authorization Holder

  Aflofarm Farmacja Polska Sp. z o.o.
  Partyzancka Street 133/151
  95-200 Pabianice
  phone: (42) 22-53-100

  Manufacturer

  Aflofarm Farmacja Polska Sp. z o.o.
  Krzywa Street 2
  95-030 Rzgów

  Date of Last Revision of the Leaflet: